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Snr Manager Safety Science - Clinical Trials

Edison-New Brunswick Metro Area, NJ

Posted: 05/30/2019 Job Type: Scientific Job Number: JN -052019-24979
Pharmacy/Nursing ( BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience
At least 4-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.
Drug Safety Experience: 2-4 yrs minimum
Provides support to activities relating to monitoring and management of Product's emerging safety profile
Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication
May contribute to preparation of materials (Slides, etc.) in preparation of CSC meetings
Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking
Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician
May provide input and support safety publication strategy :
Leads execution of all operational safety-related clinical trial activities, and may serve as the Lead Safety Scientist for a compound
Supports/May lead the strategy for surveillance activities, as appropriate
Participates in ongoing SAE reconciliation between the safety and clinical databases
Completes study-level activities generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF
Generates SAE report form, pregnancy report form, completion guidelines for trial-related activities
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